The UK's medicines regulator on Friday approved the Pfizer/BioNTech coronavirus vaccine for 12 to 15-year-olds, saying it is "safe and effective" in this age group and the benefits outweigh any risks.
Until now, COVID-19 vaccines being administered in the UK have been approved for adults aged 16 and over.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the decision followed a "rigorous review" of safety and effectiveness in the lower age groups and its conclusion is that the benefits of the vaccine far outweigh any risks.
"We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk," said Dr June Raine, MHRA Chief Executive.
"We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 15-year age group. No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met," she said.
It will now be for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group will be vaccinated as part of the deployment programme, the MHRA said.
The regulator said no new side effects were identified and the safety data in children was comparable with that seen in young adults. As in young adults, the majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness.
"We have been very careful to take into consideration the younger age group and the benefits of this population being vaccinated against any potential risk of side effects," said Professor Sir Munir Pirmohamed, Chair of the UK's Commission on Human Medicines (CHM).
He said a thorough assessment and review of the data was also looked at specifically by the CHM's Paediatric Medicines Expert Advisory Group, who are scientific experts within this age group, as well as the CHM's COVID-19 Vaccines Benefit Risk Expert Working Group.
We have concluded that based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk. The MHRA will continue to scrutinise all of the suspected side effects data received through the rigorous surveillance programme in place through the Yellow Card scheme and other safety surveillance measures for all of the COVID-19 vaccines used in the UK, said Prof Pirmohamed.
Over 2,000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials. There were no cases of COVID-19 from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group. In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years. These are extremely positive results, he added.
A Department of Health and Social Care spokesperson said the next step was for the JCVI to advise whether routine vaccination should be offered to those aged 12 to 17.
The Pfizer/BioNTech vaccine was approved for use in the UK for 16 and 17-year-olds in December 2020. The JCVI's current advice is that those aged 16 to 18 should be offered vaccination if they fall within the high-risk COVID-19 group due to an underlying condition or they are the household contacts of someone who is immunosuppressed.
At present, the JCVI stipulated vaccination programme being led by the National Health Service (NHS) in the UK is directed at age cohorts of 18 and above and there is no routine vaccination of under 18s currently underway.
The European Union (EU) recently approved the Pfizer-BioNTech vaccine for 12-15-year-olds, and the US and Canada started vaccinating children in this age group earlier this month.
Germany has indicated it will start vaccinating children over 12 from June 7.